Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ ZENODOarrow_drop_down
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
ZENODO
Report . 2024
License: CC BY
Data sources: ZENODO
ZENODO
Report . 2024
License: CC BY
Data sources: Datacite
ZENODO
Report . 2024
License: CC BY
Data sources: Datacite
versions View all 2 versions
addClaim

SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation

Authors: Durán, Carlos E.; Gini, Rosa; Davide, Messina; Riefolo, Fabio; Riera, Judit; Hoxhaj, Vjola; Mohammadi, Sima; +42 Authors

SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation

Abstract

In October 2023, the European Medicines Agency (EMA) launched a tender for building a framework for the post-authorization safety monitoring and evaluation of vaccines in the European Union (EU) and the European Economic Area (EEA). The EU PE & PV and the VAC4EU network received and implemented the tender, thus developing the SAFETY-VAC study. This report focuses on the first objective of the study aimed to provide and describe a network of data sources for the post-authorization safety monitoring and evaluation of vaccines in Europe. A multi-database cohort design study was conducted from January 1st, 2017, till the last data availability, accessing data from 10 different electronic health record data sources from seven EEA countries that have proven to be able to convert data (n=9) into the ConcePTION common data model (CDM) or are willing to do this (n=1). INSIGHT data quality level 1 and 2 checks were required and reported to assess the data quality. The results presented in this report and the corresponding fit-for-purpose assessment of the data sources are based on the currently available data instances. The study population comprised 53,283,613 persons. Incidence rates of 39 events are reported, and the coverage indicators of 12 selected vaccines were produced and benchmarked against WHO and ECDC value indicators. Finally, this report summarizes the fitness-for-purpose assessment of the participating data sources using the "Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework" (SPIFD) tool. 

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average